BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS

    MDR report key: 8352379 · Received February 19, 2019

    Report

    Report Number
    1645337-2019-08348
    Event Type
    Injury
    Date Received
    February 19, 2019
    Date of Event
    January 18, 2019
    Report Date
    January 28, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    UDI-DI
    00081317006763
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITH BLUE FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. UPON INITIAL INSPECTION THE DEVICE APPEARS INTACT. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND NO LEAK SITES WERE DETECTED. NO OTHER ANOMALIES WERE DISCOVERED. COMPLAINT WAS NOT CONFIRMED FOR DEFLATION. A MANUFACTURING RECORD EVALUATION (MRE) OF LOT NUMBER 6982497 WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. BECAUSE MENTOR PRODUCT ANALYSIS LAB WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 3/25/2019, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITH BLUE FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. UPON INITIAL INSPECTION THE DEVICE APPEARS INTACT. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND NO LEAK SITES WERE DETECTED. NO OTHER ANOMALIES WERE DISCOVERED. COMPLAINT WAS NOT CONFIRMED FOR DEFLATION. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. BECAUSE MENTOR PRODUCT ANALYSIS LAB WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 800CC AND EXPERIENCED LEFT SIDE DEFLATION OF THE TISSUE EXPANDER. THE PATIENT ALSO EXPERIENCED SEROMA ON THE LEFT BREAST. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 800CC ON (B)(6) 2019. THE PATIENT HAS FULLY RECOVERED AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145335 MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 3549216 6982497 00081317006763

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention